Roche's Chugai non-small cell lung cancer targeting drug alectinib approved by Japan

Alectinib, the latest targeted drug for anaplastic lymphoma kinase (ALK) - positive non-small cell lung cancer, has been approved for the first time in Japan The anti-tumor drug will be introduced to the Japanese market by Chugai, a subsidiary of Roche pharmaceutical, and will be officially launched later this year In the United States, the FDA has approved alectinib as an anti-tumor drug for the treatment of ALK positive non-small cell lung cancer patients who have progressed after the treatment of tezotinib, and awarded the drug the title of breakthrough therapy Tezotinib is the first ALK positive non-small cell lung cancer targeting drug, which was approved in the United States in August 2011 Since then, another specific targeted anti-tumor drug has been approved in the United States for the treatment of such patients In April, the FDA approved ceritinib in advance for the treatment of ALK positive non-small cell lung cancer patients who had previously been treated with crezolidini The approval of the antitumor drug by the Ministry of health, the labor and Welfare Bureau of Japan is based on the positive results of the phase I and phase II af-001jp clinical trials conducted in Japan, which reached the main end point with a remission rate greater than 90% Roche points out that the results of ongoing clinical trials will be used for applications in other parts of the world Chugai will also work with Ventana medical, another Roche subsidiary, to conduct alectinib's global phase III trial The above study in Japan involved patients with advanced, relapsed or unresectable non-small cell lung cancer who had received at least one chemotherapy regimen and who were ALK positive The test is divided into two parts The phase I trial included 24 patients, evaluated the safety, tolerability and pharmacokinetic parameters of the above antitumor drugs, and determined the recommended dose (300mg orally twice a day) The phase II trial included 46 patients who evaluated the efficacy and safety of the recommended dose In this study, the remission rate of alectinib group was 93.5% In addition, the progression free survival rate at 12 months was 83% Of the 70 patients who participated in the study, 14 had brain metastasis, 9 of whom had no central nervous symptoms or system progression within 12 months Roche pointed out that these patients are difficult to use other drugs for treatment, and they will continue to study this issue Alectinib's early trials have shown that it is effective in the treatment of brain metastasis, indicating that the drug can be ingested by the brain One of the ways that blood-brain barrier prevents molecules from affecting the brain is to actively expel the blood-brain barrier, a process called active efflux The company points out that the active efflux system does not recognize alectinib, which means the anti-tumor drug can enter and exit brain tissue.